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Non Small Cell Lung CancerPhase 1/2NCT03639714

A Study of a Personalized Neoantigen Cancer Vaccine

A Phase 1/2 study testing GRT-C901, GRT-R902 and nivolumab in people with Non Small Cell Lung Cancer and Colorectal Cancer, run by Gritstone bio, Inc. at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GRT-C901, GRT-R902 and nivolumab
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
11 sitesin 2 countries
Study dates
13 Feb 2019to 10 Nov 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide a signed and dated informed consent form prior to initiation of study-specific procedures.
  • Patients with the indicated advanced or metastatic solid tumor as follows:
  • NSCLC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy (note: patients who have received anti-PD-(L)1 monotherapy are eligible)
  • GEA who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
  • mUC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
  • CRC-MSS who are receiving first line systemic therapy or who are planned for or have received no more than 1 cycle of second line systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan
Show all 11Show fewer
  • 18 years of age or older
  • ECOG Performance Status 0 or 1
  • Lesion amenable to biopsy
  • Measurable disease according to RECIST v1.1
  • Have adequate organ function, as measured by laboratory values (criteria listed in protocol)

Who cannot join

  • Tumors with genetic characteristics as follows:
  • For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1, RET, or TRK
  • For CRC and GEA, patients with known MSI-high disease based on institutional standard
  • For CRC, patients with a known BRAF V600E mutation or patients with peritoneal carcinomatosis and for GEA, patients with peritoneal carcinomatosis as their only evidence of disease
  • Patients with known central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Known exposure to chimpanzee adenovirus or any history of anaphylaxis in reaction to a vaccination or allergy or hypersensitivity to study drug components
  • Bleeding disorder (eg., factor deficiency, coagulopathy) or history of significant bruising or bleeding following IM injections or blood draws
  • Complete inclusion and exclusion criteria are listed in the clinical study protocol.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

United States10 sites

  • The University of Chicago

    Chicago, Illinois, 60637

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10017

  • Columbia University Medical Center

    New York, New York, 10032

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

Australia1 site

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

Other trials in Australia

About this study

Official title: An International Phase 1/2 Study of GRT-C901/GRT-R902, a Neoantigen Cancer Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors

The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.

Read the detailed description

Tumors harboring non-synonymous deoxyribonucleic acid (DNA) mutations can present peptides containing these mutations as non-self antigens in the context of HLA on the tumor cell surface. A fraction of mutated peptides result in neoantigens capable of generating T-cell responses that exclusively target tumor cells. Sensitive detection of these mutations allows for the identification of neoantigens unique to each patient's tumor to be included in a personalized cancer vaccine that targets these neoantigens. This vaccine regimen uses two vaccine vectors as a heterologous prime/boost approach (GRT-C901 first followed by GRT-R902) to stimulate an immune response. This study will explore the safety and early clinical activity of this patient-specific immunotherapy intended to induce T-cell responses specific for neoantigens.

Being tested
GRT-C901, GRT-R902, nivolumab, ipilimumab
Keywords
neoantigen cancer vaccine, personalized neoantigen cancer vaccine, GRT-C901, GRT-R902, immunotherapy, nivolumab, ipilimumab, PD-1, CTLA-4
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Carcinoma, Transitional Cell, Diabetes Mellitus, Insulin-Dependent, 12

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GRT-C901Biological

    a patient-specific neoantigen cancer vaccine prime

  • GRT-R902Biological

    a patient-specific neoantigen cancer vaccine boost

  • nivolumabBiological

    Also called Opdivo

    anti-PD-1 monoclonal antibody

  • ipilimumabBiological

    Also called Yervoy

    anti-CTLA-4 monoclonal antibody

Study groups in NCT03639714
Study groupRoleWhat they receive
Phase 1Experimental* GRT-C901 * GRT-R902 * nivolumab * ipilimumab
Receives: Biological: GRT-C901; Biological: GRT-R902; Biological: nivolumab; Biological: ipilimumab
Phase 2 CohortsExperimental* GRT-C901 * GRT-R902 * nivolumab * ipilimumab
Receives: Biological: GRT-C901; Biological: GRT-R902; Biological: nivolumab; Biological: ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)

    Measured: Initiation of study treatment through 100 days post-last dose (up to approximately 27 months)

  2. Objective Response Rate (ORR) in Phase 2 using RECIST v1.1

    Measured: Initiation of study treatment until disease progression (up to approximately 27 months)

  3. Identify the recommended Phase 2 dose (RP2D) of GRT-C901 and GRT-R902

    Measured: Up to approximately 6 months

Secondary outcomes (7)

  1. Measure the immune response to neoantigens encoded by GRT-C901 and GRT-R902

    Measured: Baseline to end of treatment (up to approximately 12 months)

  2. Objective Response Rate (ORR) in Phase 1 using RECIST v1.1

    Measured: Initiation of study treatment until disease progression (up to approximately 4 years)

  3. Duration of response (DOR) using RECIST v1.1

    Measured: Initiation of study treatment until disease progression (up to approximately 4 years)

  4. Clinical benefit rate (using RECIST v1.1)

    Measured: Initiation of study treatment until disease progression (up to approximately 4 years)

  5. Progression-free survival (PFS)

    Measured: Up to approximately 4 years

  6. Overall survival (OS)

    Measured: Up to approximately 4 years

  7. Percentage of patients for whom vaccine is successfully manufactured and timeframe for vaccine manufacturing

    Measured: Study enrollment to initiation of study treatment (up to approximately 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2018
  2. Study start13 Feb 2019
  3. Primary completion10 Nov 2022
  4. Study completion10 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03639714
Sponsor's protocol ID
GO-004
Status last verified
Sep 2023
First submitted
6 Aug 2018
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Palmer CD, Rappaport AR, Davis MJ, Hart MG, Scallan CD, Hong SJ, Gitlin L, Kraemer LD, Kounlavouth S, Yang A, Smith L, Schenk D, Skoberne M, Taquechel K, Marrali M, Jaroslavsky JR, Nganje CN, Maloney E, Zhou R, Navarro-Gomez D, Greene AC, Grotenbreg G, Greer R, Blair W, Cao MD, Chan S, Bae K, Spira AI, Roychowdhury S, Carbone DP, Henick BS, Drake CG, Solomon BJ, Ahn DH, Mahipal A, Maron SB, Johnson B, Rousseau R, Yelensky R, Liao CY, Catenacci DVT, Allen A, Ferguson AR, Jooss K. Individualized, heterologous chimpanzee adenovirus and self-amplifying mRNA neoantigen vaccine for advanced metastatic solid tumors: phase 1 trial interim results. Nat Med. 2022 Aug;28(8):1619-1629. doi: 10.1038/s41591-022-01937-6. Epub 2022 Aug 15.

    PubMed 35970920

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GRT-C901, GRT-R902 and nivolumab in people with Non Small Cell Lung Cancer and Colorectal Cancer, run by Gritstone bio, Inc. at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) (time frame: Initiation of study treatment through 100 days post-last dose (up to approximately 27 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03639714, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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